MAUDE Adverse Event Report: HERAEUS KULZER, LLC IVORY CLAMP SS 14A REG MOLAR; RUBBER DAM CLAMP

Catalog Number 50057356

Device Problem Pitted (1460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

This incident occurred in (b)(6).The office was using hu-friedy forceps, which can lead to hyperextension and excessive forces being placed on the bow of the ivory clamp.These forces and hyperextension can lead to the breakage of the clamp.Also noticed during the evaluation in the breakage area were a couple of small voids in the metal that could have contributed to this breakage.Due to the forceps used as described and the possible voids, this incident is impossible to conclude with 100% certainty which factor caused the malfunction.

Event Description

Clamp broke the first time in use.Clamp broke while on the forceps, getting ready to place into the mouth.Clamp broke outside of the patient's mouth.Office is using hu-friedy forceps (non heraeus kulzer forceps).A rubber dam was not being utilized for the procedure.Clamp was only ligated on one side.

• Brand Name: IVORY CLAMP SS 14A REG MOLAR
• Type of Device: RUBBER DAM CLAMP
• Manufacturer (Section D): HERAEUS KULZER, LLC; 4315 lafayette blvd.; south bend IN 46614 2517
• Manufacturer (Section G): HERAEUS KULZER, LLC; 4315 lafayette blvd.; south bend IN 46614 2517
• Manufacturer Contact: amber brown ; 4315 lafayette blvd.; south bend, IN 46614 ; 5742995411
• MDR Report Key: 5951685
• MDR Text Key: 54761056
• Report Number: 1821514-2016-00027
• Device Sequence Number: 1
• Product Code: EEF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: 50057356
• Device Lot Number: M5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other